First-in-human study evaluates weekly IV Sapu003 in advanced mTOR-sensitive solid tumors, including HR+/HER2- breast cancer, RCC, NETs, TSC-associated tumors, and HCC
SAN DIEGO, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Sapu Nano today announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle™ formulation of everolimus.
The trial: SP-03-B101 — Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles.
The study includes two cohorts. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with endocrine therapy. Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety.
“This first-patient-dosed milestone represents an important step in advancing Sapu003 from clinical readiness into active patient treatment,” said Dr. Vuong Trieu, Chief Executive Officer. “Everolimus is a validated mTOR inhibitor with established activity across multiple cancers, but oral delivery has limitations including variable absorption and dose-limiting toxicity. Sapu003 was designed to re-engineer everolimus as a weekly IV Deciparticle™ formulation, with the goal of improving exposure control and expanding the therapeutic potential of mTOR inhibition.”
The Sapu003 program was featured at the 2025 San Antonio Breast Cancer Symposium, held December 9–12, 2025. The Sapu003 program is being developed in collaboration with Southern Oncology Clinical Research Unit, iNGENū CRO, and Shanghai Medicilon, supporting the clinical, translational, pharmacokinetic, and manufacturing development of Sapu003.
About Sapu Nano
Sapu Nano is a biotechnology company developing next-generation nanomedicine platforms to improve drug delivery, enhance therapeutic index, and unlock new clinical potential for established and novel therapeutics, with a primary focus in oncology. For more information, visit www.sapunano.com.
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source: Sapu Bioscience, LLC
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